Dr. Jonathan Merrell: Butterfly BVM (2/14/23)

Hey, Peter, are you there?

Hey, Peter, can you hear me okay?

Hey, Paul. Yeah, I can hear you.

Good. I just dragged up. I've just arrived up at Parkland. I'm gonna have to transition into the building. But do you get the. Do you get the CME code for today?

I did not. Let me. Let me get it. Let me.

Started recording but not be on. Okay, got it. I got. Angus.

Let me. Let me get it right now. In the meantime, let me see if. John, are you here and can you. You want to see if you can test out your.

I'm here.

Yeah. Paul, would you mind taking off your video?

Yeah, I'm going to turn everything on.

I'm going to turn it all off.

Thank you. Yeah, only because it's. It's. It's a lot of movement. Okay, thank you. I just put the CME in there today for today and. Oh, actually, let me.

Let me actually go into WhatsApp and let everyone know that we're starting. So just give me one second.

Good.

Let me do this.

All right, that's one.

Two.

And then last but not least.

Three.

Okay.

All right. Hey, John, how are you doing?

Fine, thanks.

Thanks for coming on today.

Sure.

People start rolling in here as we speak, so I appreciate you coming on. And you want to just test the. The share.

Let's do that.

If you're going to be sharing something, let's just test it out real quick. Okay, good.

Okay. It just had it up there and now it's. Hold on, let me.

Let me see if I can.

Teams is not my friend.

Usually that's the worst.

Let me try this. Let me try sharing the whole screen and then see if I can pull this up. Did I go to my presentation?

Yeah, yeah. Except that. There you go. Perfect. Perfect. You're good.

Okay, cool. Good. I can't see anybody else, but we'll go with this.

Yeah, it's all. It's all good. It's all good. So we're going to be recording this and so we'll get. We'll get a lot of distribution after the fact. So. By the way, this is. We're on our 101st webinar and this all started back thanks to Covid a couple years back. And so gotta give Paul all the credit for getting us together. And you're number 101 today, so this is exciting. Awesome. So we appreciate you coming.

Peter. Peter. The interesting thing is that we had the first one of these on February 20th, so that'll be next week to see now back in 2020.

Wow. February 20th. That's kind of when the world really didn't even know about what was going on yet, right?

Yeah.

Okay, awesome. Well, thanks everyone for joining. It's Tuesday afternoon, 3:00 Eastern Time. And as you know, we have every week coming to us folks that I find out in the world who are doing great things. My, my request to them when they come is that they bring some data with them. And today's guest is just that person. So John Morrell is actually an engineer from uva. Got his MD degree from Eastern Virginia Medical School and then he moved to Indianapolis, started to work as a pediatrician. And while he was working in the nicu, he had the aha moment, which I'm sure he'll tell us about. And then he stepped out of the box, which not many people do, and decided to tackle something that most people think he's crazy for doing. And many of us have met John, he's at all the big conferences. And John recently had a paper, had a publication in Resuscitation plus, which just was published. Actually it's given the date March 2023. So this is really as hot off the press as you can get. We saw him recently at nmsp, we saw him prior to that at EMS World. So someone out there in the world trying to fix an age old problem. So without any further ado, John, Dr. John Morrell, if you want to give any further introduction, but I'm going to give you the microphone and take it away. Thanks for joining us.

Fantastic. Thank you, Peter. Can everybody hear me?

Yeah, we hear you.

Excellent. Perfect. I can't see anybody now that I'm sharing my screen, but I'll I know you're all out there and we'll just go forward with it. So thank you, Peter. I appreciate it. Yeah, I've got my financial disclosure slide on here. I don't know if this is for CME credits or not, but yes, I am, I do have a financial disclosure. I am the CEO of Compact Medical and looking forward to talking to you a little bit about the butterfly bvm. So just a little bit more about me. Like Peter said, my background, my engineering, my undergraduate degree was in biomedical engineering at the University of Virginia and then went into medicine. The thing about engineers is they have pretty good perspective on how to solve problems, but what they sometimes lack is a knowledge of what are the most important problems to solve. And so I was hopeful that going into medicine and then into pediatrics that I would increase my exposure to physicians and to patients and to understanding what Are the. What are the holes that really need to be filled and then someday to be able to bring those two worlds together, go back into engineering and see if we can work with problem solvers to fill those holes and to solve those problems. And so I feel very, very blessed and fortunate to have the opportunity to be working on that here with Compact Medical and really appreciate the opportunity to talk with all of you a little bit about what we're doing. So like Peter said, the, the aha moment began in NICU in Indianapolis. I was on a shift and we had a co resident working with me. We were just kind of shooting the breeze one night on a night shift, talking about the things that doctors talk about when just as a group of doctors and she pointed out, hey, as physicians, we know how to save people's lives, but we don't carry equipment with us when we're out in public. Right. You take a physician into a non clinical setting and they have a lot of know how and skills. But sometimes without the equipment, we may not be much better than a layperson at doing resuscitation. We may have to wait for the ambulance to get there too, to be able to really, really work in a resuscitation. And so that kind of started on this mission of how can I make a compact bag valve mask? I know you guys met Samir Jafre with Avive a few weeks ago. Samir is a good friend and mentor to our company. They're trying to solve the compact AED problem. To solve, you know, take care of the heart. We're trying to do the compact bag valve mass to take care of the lungs is kind of one way to think of it. And we pivot. We pivoted partway through. We started the company back in 2016 and yes, the original goal was compactness. We were just trying to make the most compact bag valve mass we possibly could. That was the whole focus at the beginning. That's why we're called Compact Medical. But a few years into it, we realized that safety is by far the much bigger issue that needs to be solved. That came out of a conversation I had with Dr. Bill McGee. He's one of the founders of Operation Smile, a wonderful humanitarian organization, does surgeries for kids all over the planet. I was talking with him about the company, about the product, and I remember we reached the end of it and he said, you know what, I don't care that much about the compactness problem that you're trying to solve, but it really bothers me to, to know that Lifesavers could injure one of my loved ones on the way to the hospital.

Through no fault of their own. Right. Because of the equipment that they've been given and.

Limitations in that equipment. It bothers me to know that they could injure my loved one on the way to the hospital. And so that was a major pivoting moment for our company. We realized, you know, what we're addressing. Compactness is good, and that's important, but. But much more important is to address safety. Trying to do.

As you know, out of hospital cardiac arrest, survival rates are really poor, right? About 10% in hospital, about 25%. And.

As we all know, in this talking to a group of physicians, you all know that these are multifactorial problems, right?

I'm getting some feedback there. Here, let me.

Yeah, yeah, hold on. Jim. Jim, you're Dr. August. There you go. He's good. Thank you.

There we go. As we know, these are multifactorial problems. So it's not like anybody could come here and say, well, if we just fix this one thing, cardiac arrest would be all fixed. It'll be all better. Right. So I'm by no means trying to simplify it, but we do know that hyperventilation has been repeatedly identified as one of the problems in cpr. And so we are on a mission to. To make CPR better by reducing hyperventilation. This is a traditional bag valve mask. As you know, if you give this to any two members of your crew, you're going to get most likely two different results with this, with this piece of equipment, right? If you give this to somebody who has large hands versus somebody who has small hands are going to get two different tidal volumes. We also know that repeatedly training and retraining and retraining users to say, hey, you need to slow down, your rate is too fast or your breaths are too big or your pressures are too high. Repeatedly retraining people over and over again has not resulted in different results outcomes. And then this is a bag valve mask you can purchase today. And this is the original bag valve mask invented by Ambu in 1957. So we feel like this has been. Look, the Ambu bag has been an amazing product that has saved countless lives. But we feel like it's time for a change. And that's why made the Butterfly bvm. So this is a render of what the Butterfly BVM looks like. I'll show you in a minute a video of the product in use. So the key features here are an adjustable title volume so you can See, this goes all the way down to infant and then it goes up into adult ranges. So it is meant to be a universal three in one product. We have Broslow and Han Tevi indicators on the dial here. And really the way this would work is when you arrive at the scene, the first question you should ask yourself is what's the size of patient I'm caring for? You set your tidal volume accordingly and then the device will help to restrict the maximum volume you can deliver to what's appropriate for that patient. There's also an adjustable pop off. This is something else that's fairly novel. Traditional bag valve masks, particularly pediatric and infant BVMs will have a pop off valve usually that vents at 40 centimeters of water. That's a great safety feature to prevent barotrauma. But I'll tell you, as a pediatrician, I resuscitate babies as a living and I have never once had to give a baby 40 centimeters of water. That's a lot of pressure. And yet when I use an infant bvm, that's really my only option.

Without a manometer to guide me, if I hit a high pressure, I'm going to hit 40 centimeters of water. And I've never had to give a baby up to this point in my career. Thankfully, I've never had to give a baby that much pressure in order to open their lungs. And yet that's the only option when you use an infant BVM or even a pediatric bvm. And with the butterfly bvm, the pop off valve is adjustable. So you can see that there's several different settings. You can go from 15 all the way up to 60 or if you really need to, you can click it into override and then it will give you an essentially an infinite pressure.

This will receive any, you know, end tidal CO2, your peep valve filter, any of the accessories that you want to add to the the butterfly bvn, you can add those just like you would any other bag valve mask. And then another thing is that there's no reservoir. You'll notice on the end of this we're able to achieve an adequate blend of oxygen without relying on on an O2 reservoir. The next is a video. We'll see if this works.

Hey there, I'm John and today I'd like to tell you a little bit about the butterfly bvm. So if you're going on a run and you arrive and find, let's say a baby who needs ventilatory support, you take your butterfly BVM and the Very first thing you would do is set your tidal volume to infant in this case, and then you would deploy the device and you're ready to use it just like you would any other bad valve mask. And you can see here that we're getting good chest rise and fall with this baby. And the butterfly BVM is restricting me to, to keep me from giving a tidal volume that would be too large for this patient. Now let's say you show up and instead of a baby, you are asked to resuscitate an adult. The butterfly BVM has not only infant setting, but has brosal and hand heavy indicators for all of the pediatric settings and then switches over to ideal body weight when we get to the adult sizes. So let's say we show up and this is an adult with an ideal body weight of 70 kilos kilograms. You would set the tidal volume to 70 kilos and that will allow the butterfly BVM to expand and deliver a larger tidal volume to that patient.

Now if for some reason you weren't getting chest rise with this, then you would certainly do the usual troubleshoots. You would look at things like masked seal or endotracheal tube placement. So this doesn't change any of that. But if you found that you needed to have a little bit larger tidal volume, the butterfly BVM will adapt to that. You just simply click to the higher setting and then you can deliver a larger volume to that patient. Now we have, this is our standard model of butterfly bvm, but we have an advanced model that has an additional feature. So this is an adjustable peak pressure dial or pop off valve. So many bag on masks have a pop off valve that vents usually something around 40cm of water. But this is, this pop off valve is in fact adjustable. So you might want to start your resuscitation at something like 20 centimeters of water. But then if you find that you need a higher pressure because you're not getting chest rise or there's some other clinical indicator that calls for it, then you would simply click to the higher setting. And the butterfly BVM will cap your peak pressure at what you set it to. What's exciting about that is it means you don't have to have a manometer. You don't need to sit there and watch a pressure gauge as it bobs up and down trying to hit the peak pressure that you want. You, you can simply click. And then the butterfly BVM will keep your peak pressures within the range that you have selected. The butterfly BVM can Be used with standard accessories so things like end Tidal, CO2.

A filter.

Peep valve, and of course O2 tubing. There is place for that on the back so you can achieve a higher blend of oxygen. Thank you so much for your time today and please have a wonderful day.

I'll pause there. Really quick. Are any questions about the device before we jump into the data?

John, can you just tell us real quick? I may know the answer to this, but is this FDA approved yet or where are you in that whole process?

Yeah, not FDA approved. We are working on that. We're right now setting up manufacturing and then we have some final testing to complete. Our goal is to be submitting to the FDA by the end of this year.

Okay, thank you. And if anybody else has any questions, feel free. Just put your hand up and we can. You can unmute your mic, but go ahead, John. Okay.

All right. I can't see anything. So if somebody has the hand up, should I pause or should I go?

Dr. Daya is asking is this a single use device?

Correct? Yes, this is single use.

Okay. Awesome.

Abdo Khoury, you have a question or. Just saying hi.

Okay, John, go ahead.

We did a pilot study at Indiana University. This was sponsored by the National Science foundation, the American Academy of Pediatrics. And this is the data that was just published in last month in Resuscitation Plus. So just really quickly, the study setup was as follows. So we had about 20 participants. We brought them in. We first had them resuscitate an adult mannequin and then a pediatric mannequin. And we had them first use the Ambusper 2 as the kind of the control to represent a traditional bvm. And then we had them use the butterfly BVM next. And you can see the general setup was this. So we first had them resuscitate the adult with the Ambusper 2. We recorded 20 breaths. We recorded the tidal volume and the rate. We then offered them a 30 second pause and then moved over to the pediatric mannequin and had them do three tests. The first was 20 breaths recorded with. We didn't give them any peak pressure target. We then added a manometer to the bvm. And then for the second test we said we wanted them to keep the pressures below 20cm of water. And then for the final test we wanted them to increase those pressures between 25 and 30 centimeters of water. We then repeated the same study with the butterfly BVM. We only gave them a 30 second introduction to the device before they had to use it. So we really wanted to just drop them in. Hey, this is something you've never seen before. It was literally a 30 second script saying, hey, this new type of bag valve mass, it opens more slowly than what you're used to and it's been set to the right settings for this patient. Ready, go. And again we recorded 20 breaths, the tidal volume, the rate, and then moved over and did the exact same pediatric test. The difference was that on the pediatric test, these bottom two where with the Ambu bag we gave them a manometer to guide them. With the butterfly bvm we just simply clicked the dial to the right setting. And then the final portion of the study was we then gave them a proper introduction to the device. We gave them a two minute explanation, we allowed them to play around with and ask questions for two minutes and then we gave them a test where we said, okay, can you set the tidal volume to what would be appropriate for this type of patient? Can you adjust your peak pressure to this setting and so forth to see did they rapidly learn how to adjust and manipulate the device according to the clinical scenario that was at hand. As far as results, this is the tidal volume data you can see here. So on the left is the adult mannequin data, the right is the pediatric mannequin data. You can see that in both cases the, the average breath delivered by the ambus per two was outside of what we would consider a typical physiologic range. So the green represents 4 mls per kg, the red represents 8 mls per kg. And, and you can also appreciate the error bars on here. So look at the, the, look at the spread here on the, with the ambus per two. And this is kind of what we, we know intuitively. This is what I was saying before. If you give the Ambu bag to one person on your crew, you're probably going to get one range set of tidal volumes. If you give that same Ambu bag to a different person on the crew, you're probably going to get slightly different tidal volumes just depending on how aggressive they are, how large their hands are, how many fingers they use to squeeze and so forth. With the butterfly bvm our average breath was within the physiologic range and the error bars you can see were much tighter, which, which just shows that you can get better consistency across multiple users. That's shown in this data as well. Again, you see that the average with the butterfly BVM is, is within that 4-8mls per kg range. But if you also look at Just the, the general tightness on these box plots. We had a couple of them like, like these users here that were, had more variability in the tidal volumes delivered. But generally speaking, these box plots were much tighter with the butterfly BVM than what you were seeing with Ambu, which just shows again that you get more variability across users and within users with an Ambu bag, a traditional or a traditional bvm, I should say, than what you see with the butterfly bvm, at least what we found in this study.

This was also important. The, this was the pressure data. So you can kind of, I mean, you can kind of ignore this, this column right here, this was when they did not have a manometer to guide them, but there were 21 failures where the Ambu bag went above 40cm of water, which is the max that the pop off valve is supposed to allow. But if you look at these columns over here, there was a total of 55 failures with the Ambusper 2 when the users had a manometer to guide them. In the first test we said, we want you to keep your pressures below 20cm of water. There were 23 failures where with the Ambu bag they exceeded 20cm of water. The max was 23.7. With the butterfly BVM there was one failure and the max where we went over was by 0.3 centimeters of water. And then on the next test where we told them to go up on their pressures, there were 32 failures with the Ambu bag hitting a max of 37.9 cm of water. There was again one failure with the butterfly BVM. And again our max was 0.4 cm of water above 30.

The other thing we found is, and this is, you can intuitively kind of anticipate this is likely to happen, but we found this to be true in the, in the data.

So what you see here, this is their baseline. This was with no manometer to guide them. This was with the manometer we told them to keep the pressures below 20. And then these two show you when we, when we asked them to increase their pressure between 25 and 30. And what you can find is that again, the title volumes of the butterfly BVM were generally within range during all three tests. What we found with the Ambu bag is that asking people to hit a lower pressure, peak pressure was actually helpful with the Ambu bag to help get the title volumes closer to within a therapeutic range. But then when we asked them to increase their pressures, you notice that the tidal volumes go back up and that is again, it's kind of intuitive. But we know that when you, when you ask somebody to watch their rate, watch their tidal volume, watch chest rise and fall and watch a manometer and make sure you keep it within range, we know that that's really too much for a human to do. And so if you tell somebody, hey, I want you to focus on peak pressures and increasing your pressures and that comes up, like I said, I resuscitate babies and that happens in nrp. There's time where you have to go up on your pressures. Well, if somebody's focusing, laser focused on trying to get those pressures just where they need to be, they're probably only focusing on that one variable and they're missing other things. They're not paying attention to rate, they're not paying attention to tidal volume and other things. And so what we're hoping to create here with the butterfly BVM is a product where you can set your volume, set your pressures and allow the user to focus more on the patient, focus on chest rise and fall, focus on end tidal CO2 indication, other things, but not be focused on trying to manage so many variables at once. Last thing I'll show is just the I told you we did the, we did a two minute. At the very end of the study, we gave them a two minute introduction, gave them two more minutes to ask questions to handle the device, and then we gave them a test where we asked them to manipulate the device. Out of 266 responses, we had a 97% success where they, they were able to make the adjustments correctly. The first.